Trauma-MISC
Catalogue number E0016787-1, listed by Smith & Nephew, Inc., United States, under Elevator. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HTE |
| Device type | Elevator |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-11-26 |
| Record revised | 2023-09-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E0016787-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Instruments | Life Instrument Corp. | 383 |
| General Instruments | Alphatec Spine, Inc. | 326 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 209 |
| Battalion | Alphatec Spine, Inc. | 152 |
| IdentiTi | Alphatec Spine, Inc. | 110 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 103 |
| Orthomed | Ortho-MED, Inc. | 100 |
| Tecomet | Tecomet, Inc. | 88 |
| Innomed, Inc. | Innomed, Inc. | 85 |
| General Instrument | Alphatec Spine, Inc. | 85 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 71 |
| Elmed | Elmed, Inc. | 67 |
Showing 12 of 246. All products under Elevator
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.